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NCT02377245 Clinical Trial

Juvenile Inflammatory Rheumatism (JIR) Cohorte

Arthritis, Juvenile Rheumatoid Clinical Trial

— JIR-cohorte  

Official title:
Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02377245
Other study ID # JIR-001
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 2014
Est. completion date December 2030

Study information
Verified date June 2023
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents.

Description:

The JIR-cohort has to be filled by an authorized investigator during or after the consultation. Each patient much be followed at least once a year. Different data are requested in the JIR-cohort: diagnosis, treatment, adverse events and outcome.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 15000
Est. completion date December 2030
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with juvenile inflammatory diseases - Age at onset up to 18 years old - Consent according national codes of ethics and current laws Exclusion Criteria: - Non-consent from patients and/or legal representative

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Hôpital Reine Fabiola Bruxelles
Belgium CHU Charleroi Charleroi
Belgium UZ Leuven Leuven
Belgium CHC Liège Liège
Belgium CHR Citadelle Liège
France CHU Belfort Belfort
France CHRU Besançon Besançon
France Hôpital Pellegrin enfants Bordeaux
France CHRU Brest Brest
France Hôpital Femme Mère Enfant Bron
France CHU Clermont-Ferrand Clermont-Ferrand
France CHU de Grenoble Grenoble
France Hôpital Bicêtre Le Kremlin Bicêtre
France CHRU Lille Lille
France Hôpital Nord Marseille Marseille
France CHU Arnaud de Villeneuve Montpellier
France Centre hospitalier de Mulhouse Mulhouse
France CHU Nantes Nantes
France Nice CHU - Lenval Nice
France CHU Nimes Nimes
France Hôpital necker Enfants Malade Paris
France Hôpital Robert Debré Paris
France Hôpital Tenon Paris
France CHU Reims Reims
France CHU Rennes Rennes
France CHU St-Etienne St-Etienne
France Hôpital de Hautepierre Strasbourg
France Hôpital des enfants Toulouse
France CHU Tours Tours
France Hôpital André Mignot Versailles
Germany University Hospital Muenster Münster
Morocco Hôpital Ibnou Rochd Casablanca
Switzerland Kantonsspital Aarau Aarau
Switzerland Kinderspital Basel Basel
Switzerland Universitäts-Augenklinik Basel Basel
Switzerland Ospedale Regionale di Bellinzona e valli Bellinzona
Switzerland Kantonspital Graubunden Chur
Switzerland CHUV Lausanne Vaud
Switzerland Hôpital Ophtalmique Lausanne
Switzerland Ospedale Regionale di Lugano Lugano
Switzerland Kinderspital Luzern Luzern
Switzerland Ostschweizer Kinderspital St-Gallen St-Gallen
Switzerland Klinik für Rheumatologie und internistische Rehabilitation Valens
Switzerland Kantonspital Winterthur Winterthur
Switzerland Kinderspital Zürich Zürich

Sponsors (8)
Lead Sponsor Collaborator
Michaël Hofer Bicetre Hospital, Fondation Rhumatismes-Enfants-Suisse, Hospices Civils de Lyon, Tenon Hospital, Paris, University Hospital Muenster, University of Lausanne Hospitals, Versailles Hospital

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Morocco,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of severe and very severe adverse event as a mesure of safety and tolerability 10 years
Primary Number of treatments prescribed off label 10 Years
Primary Length in months of drug survival in patient treated with at least two consecutive biological agents 10 Years
See also
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Completed NCT00652925 - A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA Phase 3
Completed NCT02001844 - Foot Orthoses (FOs) on Pain, Quality of Life and the Gait With Children Diagnosed With JIA N/A
Completed NCT00731965 - Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Juvenile Idiopathic Arthritis Phase 4
Completed NCT02067962 - Identification of Genes Involved in Juvenile Idiopathic Arthritis by Wholel Exome Sequencing N/A
Terminated NCT00868751 - Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis N/A
Terminated NCT00637780 - Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis Phase 4
Completed NCT00001614 - The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis Phase 1
Completed NCT01412021 - Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis
Completed NCT00426218 - Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) Phase 1/Phase 2
Completed NCT00034853 - Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA) Phase 3
Recruiting NCT06000566 - Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis
Terminated NCT00511329 - Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease Phase 2/Phase 3
Terminated NCT00688545 - Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis
Recruiting NCT00012506 - The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis Phase 3

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